Antimicrobial compositions containing cationic active ingredients

ABSTRACT

The antimicrobial composition of the present invention comprises a cationic active ingredient, a foam boosting surfactant, a foam boosting copolymer, a foam stabilizer, and a chelating agent. The present antimicrobial compositions are free of the antimicrobial agent triclosan (i.e., 2,4,4′-trichloro-2′hydroxy-diphenylether), have rapid cidal activity, provide stable copious foam and exhibit enhanced tissue (e.g. skin) compatibility as defined by an in vitro whole toxicology assessment method.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a Continuation application of U.S. Ser. No. 14/225,039, filedMarch, 2014, which is herein incorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention is directed to antimicrobial compositions, likepersonal care compositions, having improved antimicrobial efficacy andhigh foaming attributes. More particularly, the present inventionrelates to antimicrobial compositions exhibiting the antimicrobialeffectiveness of cationic active ingredients, a foam boostingsurfactant, a chelating agent, a novel foam boosting copolymer, withoptional properties of a broad spectrum of antimicrobial efficacy, highfoam and reduced irritation to mammalian tissue. The composition isessentially free of aromatic biocides such as triclosan, anionicsurfactants and C₁ to C₄ alcohols

BACKGROUND OF THE INVENTION

Antimicrobial personal care compositions are known in the art.Especially useful are antimicrobial cleansing compositions, whichtypically are used to cleanse the skin and to destroy bacteria and othermicroorganisms present on the skin, especially the hands, arms, and faceof the user.

Antimicrobial compositions are used, for example, in the health careindustry; long term care, hospitality and health/exercise facilities;food service industry, meat processing industry, and in the privatesector by individual consumers. The widespread use of antimicrobialcompositions indicates the importance consumers place on controllingbacteria and other microorganism populations on skin. It is important,however, that antimicrobial populations provide a substantial and broadspectrum reduction in microorganism populations quickly and withoutproblems associated with toxicity and skin irritation.

In particular, antimicrobial cleansing compositions typically contain anactive antimicrobial agent, an anionic surfactant for cleansing and foamgeneration, skin conditioning agents for cosmetic effects, and dyes,perfumes, and optional thickening agents, such as clays, polymers,cellulosic derivatives, or colloids, for aesthetic effects, all in anaqueous carrier.

Several different classes of antimicrobial agents have been used inantimicrobial cleansing compositions. These include active ingredientsselected from the following classes: phenolic compounds, carbanalidecompounds, lower alcohols, surface active agents halogens, andcarboxylic acids. Each of these classes has their own unique advantagesand challenges. Examples of specific antimicrobial agents include PCMX(para-chlorometa xylenol), Triclosan, Triclocarban, benzyl alcohol,quaternary ammonium compounds (QAC), iodine and iodine complexes andbiguanides (e.g., chlorhexidine digluconate). At this time Triclosan isthe dominant antimicrobial active ingredient in the dermal cleansermarket.

Although there is an increasing consumer demand for products which haveboth an activity against bacteria and other microorganisms, there is aneven greater demand to fulfill the consumer's expectations with regardto their level of concern with certain biocides such as Triclocarban andTriclosan.

Triclosan is disfavored as an antimicrobial agent due to environmentalpersistence and health concerns due to the possible formation ofintermediate and/or environmental by products. Thus, a need exists foran efficacious antimicrobial personal care composition which issubstantially free of biocides such as Triclocarban and Triclosan butthat still provides a high foam level desired by consumers and is mildto the skin. The present invention is directed to such antimicrobialcompositions.

The above-mentioned disadvantages of current antimicrobial compositionsare addressed by embodiments of the present invention and will beunderstood by reading and studying the following specification. Thefollowing summary is made by way of example and not by way oflimitation. It is merely provided to aid the reader in understandingsome of the aspects of the invention.

SUMMARY OF THE INVENTION

In accordance with the present invention, a composition that exhibitsrapid cidal efficacy and high foaming attributes is provided. Theantimicrobial composition comprises a cationic active ingredient, a foamboosting surfactant which may encompass nonionic surfactants, cationicsurfactants or amphoteric surfactants, a novel foam boosting copolymer,a chelating agent, a foam stabilizer and water. The presentantimicrobial compositions are free of the antimicrobial agent triclosan(i.e., 2,4,4′-trichloro-2′hydroxy-diphenylether), anionic surfactantsand C₁ to C₄ alcohols and have rapid cidal efficacy. The compositionsalso provide stable copious foam and may optionally contain ingredientsto increase skin compatibility and skin health.

Accordingly, one aspect of the present invention is to provide anantimicrobial composition for reducing microbial population on dermaltissue, the antimicrobial composition comprising: (a) about 0.1 wt. % toabout 10.0 wt. %, by weight of cationic actives; (b) about 0.1 wt. % toabout 20 wt. %, by weight of a foam boosting surfactant; (c) about 0.5wt. % to about 25 wt. % dermal adjuvants (d) about 0.05 wt. % to about12.0 wt. %, by weight of a foam boosting polymer, (e) about 0.1 wt. % toabout 10 wt. % of a foam stabilizer, (f) from about 0.1 wt. % about 6.0wt. % of a chelating agent such that the chelating agent forms acalcium-chelating agent complex with a stability constant (expressed inlogarithmic form) greater than 5.5 and (g) water or other suitablediluent wherein the composition it essentially free of triclosan,anionic surfactants and C₁ to C₄ alcohols.

Another aspect of the present invention is to provide an antimicrobialcomposition for reducing microbial population on dermal tissue which isstable and has a pH of about 4.0 to about 9.0. The present compositionalso exhibits excellent esthetic properties, such as copious foam andfoam stability and may optionally contain ingredients to increase skincompatibility and skin health. Moreover, the composition may exhibitreduced tissue irritancy potential.

A further aspect of the present invention is to provide personal useproducts based on an antimicrobial composition of the present invention,for example, a skin cleanser, a surgical scrub, a hand sanitizer gel, adisinfectant, antiseptic wash, and the like.

A further aspect of the present invention is to provide a method ofreducing gram positive and/or gram negative bacteria populations onmammalian tissue, including human tissue, by contacting the tissue, likethe dermis, with a composition of the present invention for a sufficienttime, such as about 15 seconds to 5 minutes, to reduce the bacterialevel to a desired level. Antimicrobial efficacy is applicable to viraland fungal organisms as well as gram positive and gram negativebacteria.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the detaileddescription is to be regarded as illustrative in nature and notrestrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a graph depicting the tests results of the efficacyfollowing a 30 second exposure time of three different cationic activeingredients, specifically, 0.5% quat (benzalkonium chloride), 2% CHG(chlorhexidine gluconate), and 1% PHMB (polyhexamethylene biguanide) ina representative surfactant system.

FIG. 2 illustrates a graph depicting the test results of the efficacyagainst S. aureus and E. coli bacteria with increased concentrations ofquaternary sugar-derived surfactants, specifically, poly(trimoniumhydroxypropyl cocogluocosides chloride). The amount and typeof cationic active ingredient (0.5% ADBAC) and foam boosting surfactant(1.95% alkyl dimethyl amine oxide) was held constant.

FIG. 3 illustrates a graph depicting the test results of the efficacywith increased concentrations of foam boosting surfactants,specifically, amine oxide. The amount and type of cationic activeingredient (0.5% ADBAC) and quaternary sugar-derived surfactant (1.25%poly trimoniumhydroxypropyl cocoglucosides chloride) were held constant.

FIG. 4 illustrates the dermal irritancy (mildness) of the preferredembodiment for an antimicrobial dermal cleanser to four commerciallyavailable antimicrobial soaps.

FIG. 5 illustrates the foam profile of the preferred embodiment for anantimicrobial dermal cleanser to three commercially availableantimicrobial soaps.

FIG. 6 illustrates the efficacy against S. aureus and E. coli bacteriafollowing a 30 second exposure to a cationic active in combination withquaternary sugar-derived surfactants, held constant at 1.25% and ann-alkyl (C₁₂₋₁₆) dimethylamine oxide foam boosting surfactant.

FIG. 7 illustrates the foam rigidity of the preferred embodiment for anantimicrobial dermal cleanser to two commercially availableantimicrobial soaps with cationic actives.

FIG. 8 is a graph showing the efficacy against S. aureus and E. colibacteria over various pHs.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Other than in the operating examples, or where otherwise indicated, allnumbers expressing quantities of ingredients or reaction conditions usedherein are to be understood as being modified in all instances by theterm “about”.

As used herein, weight percent (wt-%), percent by weight, % by weight,and the like are synonyms that refer to the concentration of a substanceas the weight of that substance divided by the total weight of thecomposition and multiplied by 100.

As used herein, the term “about” modifying the quantity of an ingredientin the compositions of the invention or employed in the methods of theinvention refers to variation in the numerical quantity that can occur,for example, through typical measuring and liquid handling proceduresused for making concentrates or use solutions in the real world; throughinadvertent error in these procedures; through differences in themanufacture, source, or purity of the ingredients employed to make thecompositions or carry out the methods; and the like. The term about alsoencompasses amounts that differ due to different equilibrium conditionsfor a composition resulting from a particular initial mixture. Whetheror not modified by the term “about,” the claims include equivalents tothe quantities.

As used herein, the term “cationic active” is defined as the ingredientthat provides antimicrobial cidal activity.

As used herein, the term “skin care active” is defined as the ingredientor ingredients that improve or maintain the health of the dermalbarrier.

The term “alkyl” refers to a straight or branched chain monovalenthydrocarbon radical having a specified number of carbon atoms. As usedherein, “alkyl” refers to a linear or branched C₆-C₁₈ carbon chain.

The term “microbial” or “microbial population” refers to bacterial,fungal, yeast, or viral population or combinations thereof or anymixture thereof in a laboratory or natural setting.

The term rapid cidal efficacy refers to ≧3 log kill in up to 60 secondsin the in vitro time kill test ASTM E 2315.

The term “surfactant” or “surface active agent” refers to an organicchemical that when added to a liquid changes the properties of thatliquid at a surface or interface.

“Cleansing” means to perform or aid in soil removal, bleaching,microbial population reduction, rinsing, or combination thereof.

As used herein, the term “free” refers to compositions completelylacking the component or having such a small amount of the componentthat the component does not affect the effectiveness of the composition.The component may be present as an impurity or as a contaminant andshall be less than 0.5 wt. %. In another embodiment, the amount of thecomponent is less than 0.1 wt. % and in yet another embodiment, theamount of component is less than 0.01 wt. %.

It should be noted that, as used in this specification and the appendedclaims, the singular forms “a”, “an”, and “the” include plural referentsunless the content clearly dictates otherwise. Thus, for example,reference to a composition containing “a compound” includes a mixture oftwo or more compounds. It should also be noted that the term “or” isgenerally employed in its sense including “and/or” unless the contentclearly dictates otherwise.

The term “actives” or “percent actives” or “percent by weight actives”or “actives concentration” are used interchangeably herein and refers tothe concentration of those ingredients involved in cleansing expressedas a percentage minus inert ingredients such as water or salts.

As used herein, the terms “triclosan free” or “free of triclosan” refersto a composition, mixture, or ingredients that do not contain triclosan(2,4,4′-trichloro-2′hydroxy-diphenylether) or triclosan containingcompounds or to which the same has not been added. Should triclosan ortriclosan containing compounds be present through contamination of acomposition, mixture, or ingredients, the amount of the same shall beless than 0.5 wt. %. In another embodiment, the amount of is less than0.1 wt. % and in yet another embodiment, the amount is less than 0.01wt. %.

Antimicrobial Compositions Containing Cationic Active Compounds

The present invention relates to an antimicrobial composition thatexhibits rapid cidal antimicrobial efficacy and high foaming attributes.The antimicrobial composition comprises a cationic active ingredient, afoam boosting surfactant which may encompass anionic surfactants,nonionic surfactants, amphoteric surfactants, or cationic surfactantsand water. The present antimicrobial compositions are free of theantimicrobial agent triclosan (i.e.,2,4,4′-trichloro-2′hydroxy-diphenylether), anionic surfactants and C₁ toC₄ alcohols, has rapid cidal efficacy and provide stable copious foamand may optionally contain ingredients to increase skin compatibilityand skin health.

In one embodiment, an antimicrobial composition for reducing microbialpopulation on dermal tissue includes: (a) about 0.1 wt. % to about 10.0wt. %, by weight of cationic actives; (b) about 0.1 wt. % to about 20wt. %, by weight of a foam boosting surfactant; (c) about 0.5 wt. % toabout 25 wt. % dermal adjuvants and (d) water or other suitable diluent.

Another aspect of the present invention is to provide an antimicrobialcomposition for reducing microbial population on dermal tissue which isstable and has a pH of about 5.0 to about 8.0. The present compositionalso surprisingly exhibits excellent esthetic properties, such ascopious foam and foam stability and may optionally contain ingredientsto increase skin compatibility and skin health. Moreover, thecomposition may exhibit reduced tissue irritancy potential.

A further aspect of the present invention is to provide personal useproducts based on an antimicrobial composition of the present invention,for example, a skin cleanser, a surgical scrub, a hand sanitizer gel, adisinfectant, and the like.

A further aspect of the present invention is to provide a method ofreducing gram positive and/or gram negative bacteria populations onmammalian tissue, including human tissue, by contacting the tissue, likethe dermis, with a composition of the present invention for a sufficienttime, such as about 30 seconds to 5 minutes, to reduce the bacterialevel to a desired level.

The following illustrates non-limiting embodiments of the presentinvention.

Cationic Actives

A cationic active is present in an antimicrobial composition forreducing microbial population on the dermal tissue of a mammal of thepresent invention in an amount of about 0.1 wt. % to about 10.0 wt. %,and preferably about 0.1 wt. % to about 5.0 wt. %, by weight of thecomposition.

The amount of antimicrobial agent in the composition is related to theend use of the composition, The amount of antimicrobial agent issufficient in the compositions of the invention to achieve a microbialkill in a short contact time, for example, 15 to 30 seconds.

Cationic active ingredients are an antimicrobial agent useful in thepresent invention. The cationic or cationically-active ingredients aresubstances based on nitrogen centered cationic moieties with netpositive change. The cationic or cationically-active ingredients arepreferably selected from the group consisting of cationic polymers,cationic surfactants, cationic monomers, cationic silicon compounds,cationic derivatized protein hydrolyzates and betaine with at least onecationic or cationically-active group.

Suitable cationic active ingredients contain quaternary ammonium groups.Suitable cationic active ingredients especially include those of thegeneral formula:

N⁽⁺⁾R¹R²R³R⁴X⁽⁻⁾

wherein R², R³ and R⁴ independently of each other represent alkylgroups, aliphatic groups, aromatic groups, alkoxy groups,polyoxyalkylene groups, alkylamido groups, hydroxyalkyl groups, arylgroups, H⁺ ions, each with from 1 to 22 carbon atoms, with the provisionthat at least one of the groups R¹, R², R³ and R⁴ has at least eightcarbon atoms and wherein X(−) represents an anion, for example, ahalogen, acetate, phosphate, nitrate or alkyl sulfate, preferably achloride. The aliphatic groups can also contain cross-linking or othergroups, for example additional amino groups, in addition to the carbonand hydrogen atoms.

Particular cationic active ingredients include, for example, but are notlimited to, alkyl dimethyl benzyl ammonium chloride (ADBAC), alkyldimethyl ethylbenzyl ammonium chloride, dialkyl dimethyl ammoniumchloride, benzethonium chloride, N, N-bis-(3-aminopropyl) dodecylamine,chlorhexidine gluconate, an organic and/or organic salt of chlorhexidinegluconate, PHMB (polyhexamethylene biguanide), salt of a biguanide, asubstituted biguanide derivative, an organic salt of a quaternaryammonium containing compound or an inorganic salt of a quaternaryammonium containing compound or mixtures thereof.

In accordance with an important feature of the present invention, apresent antimicrobial composition is substantially free of triclosan.The phrase “substantially free” of triclosan is defined as meaning thatthe composition contains 0% to about 0.25% by weight, in total, oftriclosan. In particular, triclosan may be present in an antimicrobialcomposition in a total amount of 0.25% or less either as a by-product oras a component of an ingredient in the composition, but triclosan is notintentionally introduced into the composition.

Triclosan is disfavored as an antimicrobial agent due to environmentaland health concerns due to the possible formation of intermediate and/orenvironmental by products.

Foam-Boosting Surfactant

In addition to an antimicrobial agent, and a quaternized sugar-derivedsurfactant the present antimicrobial composition for reducing microbialpopulation on the dermal tissue of a mammal of the present inventionalso contains one or more foam boosting surfactants. The one or morefoam booting surfactants is present in an amount of about 0.1% to about40.0%, and preferably about 1% to about 25%, by weight, of thecomposition.

The amount of foam boosting surfactant present in the composition isrelated to the amount of the cationic active in the composition, theamount of the quaternized sugar-derived surfactant in the composition,the identity of the foam boosting surfactant, and the end use of thecomposition.

The foam-boosting surfactant can be (a) nonionic surfactants or cationicsurfactants, or mixtures thereof. The formulation is essentially free ofanionic or zwitteronic surfactants.

Non Ionic Foam Boosting Surfactant

Examples of non ionic foam-boosting co-surfactants include, but are notlimited to, alkyl amine oxide, alkyl ether amine oxide, alkyl alcoholalkoxylates, aryl alcohol alkoxylates, substituted alcohol alkoxylates,block nonionic copolymers, heteric nonionic copolymers, alkanolamides,substituted amides, or polyethoxylated glycerol derivatives.

The antimicrobial composition can contain a nonionic surfactantcomponent that includes a detersive amount of nonionic surfactant or amixture of nonionic surfactants. Typically, a nonionic surfactant has ahydrophobic region, such as a long chain alkyl group or an alkylatedaryl group, and a hydrophilic group comprising an ethoxy and/or otherhydrophilic moieties. As defined herein, a “nonionic foam-boostingsurfactant” has a hydrophobic region having an alkyl group containingsix to eighteen carbon atoms, and an average of one to about twentyethoxy and/or propoxy moieties. Examples of non ionic foam-boostingco-surfactants include, but are not limited to, alkyl amine oxide, alkylether amine oxide, alkyl alcohol alkoxylates, aryl alcohol alkoxylates,substituted alcohol alkoxylates, block nonionic copolymers, hetericnonionic copolymers, alkanolamides, or polyethoxylated glycerol esters,and mixtures thereof.

Numerous other nonionic surfactants are disclosed in McCutcheon'sDetergents and Emulsifiers, 1993 Annuals, published by McCutcheonDivision, MC Publishing Co., Glen Rock, N.J., pp. 1-246 and 266-273; inthe CTFA International Cosmetic Ingredient Dictionary, Fourth Ed.,Cosmetic, Toiletry and Fragrance Association, Washington, D.C. (1991)(hereinafter the CTFA Dictionary) at pages 1-651; and in the CTFACosmetic Ingredient Handbook, First Ed., Cosmetic, Toiletry andFragrance Association, Washington, D.C. (1988) (hereafter the CTFAHandbook), at pages 86-94, each incorporated herein by reference.

Amphoteric Foam Boosting Surfactant

The antimicrobial composition can contain an amphoteric surfactantcomponent that includes a detersive amount of amphoteric surfactant or amixture of amphoteric surfactants. Suitable amphoteric surfactants thatcan be used include, but are not limited to, imidazolines andimidazoline derivatives, isethionates, betaine derivatives, amphoacetatederivatives, propionates, and mixtures thereof.

Cationic Foam Boosting Surfactant

The antimicrobial composition may contain a cationic surfactantcomponent that includes a detersive amount of cationic surfactant or amixture of cationic surfactants. Cationic surfactants that can be usedin the antimicrobial composition include, but are not limited to,quaternized sugar-derived surfactants, quaternized polysaccharides,alkyl polysaccharides, alkoxylated amines, alkoxylated ether amines,phospholipids, phospholipid derivatives, and mixtures thereof.Particularly preferred is a quaternized sugar-derived surfactant. Thequaternized sugar surfactant may be present in an amount of about 0.1%to about 18%, and preferably about 0.25% to about 12.5%, by weight, ofthe composition.

The amount of quaternized sugar-derived surfactant present in thecomposition is related to the amount of the cationic active in thecomposition, to the identity of the quaternized sugar-derivedsurfactant, and the end use of the composition.

The quaternized sugar-derived surfactant is a quaternized alkylpolyglucoside or a polyquaternized alkyl polyglucoside, and the like.

In one embodiment, the antimicrobial composition of the presentinvention includes a polyquaternary functionalized alkyl polyglucoside,a cationic active ingredient, water, and an optional foam boostingsurfactant. The poly quaternary functionalized alkyl polyglucoside is acationic surfactant naturally derived from alkyl polyglucosides and hasa sugar backbone. Poly quaternary alkyl polyglucosides have thefollowing representative formula:

Wherein R is an alkyl group having from about 6 to about 22 carbon atomsand n is an integer ranging from 4 to 6. Examples of suitable polyquaternary functionalized alkyl polyglucosides components which can beused in the cleansing compositions according to the present inventioninclude those in which the R alkyl moiety contains from about 8 to about12-carbon atoms. In a preferred embodiment the quaternary functionalizedalkyl polyglucoside contains primarily about 10-12 carbon atoms.Examples of commercially suitable poly quaternary functionalized alkylpolyglucosides useful in cleansing compositions of the present inventioninclude but is not limited to: Poly Suga®Quat series of quaternaryfunctionalized alkyl polyglucosides, available from Colonial Chemical,Inc., located in South Pittsburgh, Tenn.

In another embodiment, the antimicrobial composition of the presentinvention includes a quaternary functionalized alkyl polyglucoside, acationic active ingredient, water, and an optional foam boostingsurfactant. The quaternary functionalized alkyl polyglucoside is anaturally derived cationic surfactant from alkyl polyglucosides and hasa sugar backbone. Quaternary functionalized alkyl polyglucosides havethe following representative formula:

Wherein R₁ is an alkyl group having from about 6 to about 22 carbonatoms, and R₂ is CH₃(CH₂)_(n′) where n′ is an integer ranging from 0-21.Examples of suitable quaternary functionalized alkyl polyglucosidescomponents which can be used in the cleansing compositions according tothe present invention include those in which the R₁ alkyl moietycontains primarily about 10-12 carbon atoms, the R₂ group is CH₃ and nis the degree of polymerization of 1-2. Further examples of a suitablequaternary functionalized alkyl polyglucoside include, but are notlimited to, the antimicrobial and antifungal quaternary functionalizedalkyl polyglucosides described in U.S. Pat. Nos. 7,084,129 and 7,507,399the disclosures of which are hereby incorporated by reference. Examplesof commercially suitable quaternary functionalized alkyl polyglucosidesuseful in cleansing compositions of the present invention include but isnot limited to: Suga®Quat TM 1212 (primarily C₁₂ quaternaryfunctionalized alkyl polyglucoside), Suga®Quat L 1210 (primarily C₁₂quaternary functionalized alkyl polyglucoside), and Suga®Quat S 1218(primarily C₁₂ quaternary functionalized alkyl polyglucoside) availablefrom Colonial Chemical, Inc., located in South Pittsburgh, Tenn.

Dermal Adjuvant/Skin Care Active

The composition can contain from about 1 wt. % to about 30 wt. % ofdermal adjuvants, preferably from about 5 wt. % to about 25 wt. % ofdermal adjuvants. Dermal adjuvants/skin care actives generally includeany substance which improves or maintains the health of the dermalbarrier. Some examples include but are not limited to emollients andskin moisturizer/protectants.

1) Emollients

The composition can include emollients which are polymers such asdimethyl siloxanes Examples of high include but are not limited todicaprylyl carbonate, dibutyl adipate, hexyl laurate, dicaprylyl ether,propylheptyl caprylate, 4-10 centistoke silicone oil, D4, 5, or 6 cyclicsiloxane, isocetyl palmitate, hydrogenated polyisobutene, anddiethylhexylcarbonate.

polymers such as dimethyl siloxanes examples include capric/caprylictriglyceride, C12-15 alkyl benzoate, capric triglyceride, caprylictriglyceride, isopropyl myristrate, isopropyl palmitate, octyldodecanol,decyl oleate, cocoglycerides, ethylhexyl stearate, cetearylisononanoate, cetearyl ethyhexanonate, decyl cocoate, cetyl dimethicone,ethylhexyl palmitate, PPG-11 stearyl ether, PPG-15 stearyl ether,Dimethicone fluid, and PPG-14 butyl ether.

These materials also may include polymers such as siloxanes examplesinclude mono-, di-, and tri-glycerides and butters and hydrogenatedversions of seed and nut oils including but not limited to; palm oil,coconut oil, vegetable oil, avocado oil, canola oil, corn oil, soy beanoil, sunflower oil, safflower oil, meadowfoam seed oil, bilberry seedoil, watermelon seed oil, olive oil, cranberry, macadamia nut oil, arganoil, pomegranate oil, argan moraccan oil, blue berry oil, raspberry oil,walnut oil, pecan oil, peanut oil, bayberry oil, mango seed oil, Manilaoil, castor oil: Shea butter, jojoba oil, hydrolyzed jojoba oil,Carnauba butter, Carnauba wax, castor isostearate succinate stearylheptanoate, cetyl ricinoleate, oleyl frucate, sucrose monostearate,sucrose distearate, sucrose tristearate, sucrose tetrastearate, candelawax, soybean wax, Rapeseed wax, palm wax, bees wax, petrolatum, myristylmyristate, Oleyl Erucate, squalane, stearyl alcohol, Cetearylisononanoate, polyisobutene, glyceryl stearate, glyceryl distearate,cetyl alcohol, lanolin, lanolin ethoxylate, low molecular weightpolyethylene waxes, lower molecular weight polypropylene waxes, PEG-30glyceryl cocoate, PEG-80 Glyceryl cocoate, PEG-30 Glyceryl stearate,PEG-8 Ricinoleate, PEG-8 Raspberriate, Linear (otherwise known as bis)and Pendent versions of including hydroxyl terminated and methyl etherterminated; PEG-3 to PEG-32 Dimethicone (including but not limited to:PEG-3 Dimethicone, PEG-8 Dimethicone, PEG-9 Dimethicone, PEG-10Dimethicone, PEG-11 Methyl ether dimethicone, PEG-12 Dimethicone, PEG-14Dimethicone, PEG-17 Dimethicone, PEG-32 Dimethicone), bis-PEG/PPG-20/20Dimethicone, PEG/PPG 20/23 Dimethicone, PEG/PPG 20/22 Butyl EtherDimethicone, PEG/PPG 23/6 Dimethicone, PEG/PPG 20/15 Dimethicone.

Alkyl modified dimethicone (stearoxy dimethicone, behenoxy dimethicone,cetyl dimethicone, certeryl methicone C30-45 Alkyl cetearyl dimethiconecopolymer, C30-45 Alkyl dimethicone, caprylyl methicone, PEG-8dimethicone/dimer dilinoleic acid copolymer, Bis-PEG-10Dimethicone/Dimer Dilinoleate Copolymer, Stearoxymethicone/DimethiconeCopolymer, Dipheyl dimethicone, Lauryl polyglycerol-3polydimethylsiloxyethyl dimethicone, Lauryl PEG-9polydimethylsiloxyethyl dimethicone), Dimethicone fluid (>20 cst),quaternized ammonia silicone polymers, Amino silicones, siliconequaternium-18, Amodimethicone, phenyltrimethicone, amino siliconepolyethers, Polyglycerol-3 Disiloxane dimethicone, Polyglycerol-3polydimethylsiloxyethyl dimethicone, and PEG-9 polydimethylsiloxyethyldimethicone.

Emollients, if present may be in an amount of from about 0.01 wt. % toabout 10 wt. %, preferably from about 0.05 wt. % to about 8 wt. % andmore preferably from about 0.1 wt. % to about 5 wt. %.

2) Skin Moisturizer/Protectant

The composition can include at least one additional skin conditionersuch as vitamins, a humectant, an occlusive agent, or other moisturizerto provide skin moisturizing, skin softening, skin barrier maintenance,anti-irritation, or other skin health benefits. Some non-limitingexamples of additional skin conditioners include alkyl benzoate,myristyl myristate, cetyl myristate, gelatin, carboxylic acid, lacticacid, glyceryl dioleate, methyl laurate, PPG-9 laurate, lauryl lacylateallantoin, octyl palmitate, lanolin, propylene glycol, butylene glycol,ethylene glycol, caprylyl glycol, monobutyl ether, glycerine, fattyacids, proline, natural oils such as almond, mineral, canola, sesame,soybean, pyrrolidine, wheat germ, hydrolyzed wheat protein, hydrolyzedoat protein, hydrolyzed collagen, corn, peanut and olive oil, isopropylmyristate, myristyl alcohol, aloe vera, algae extract, gluconic acid,hydrolyzed silk protein, 1,3-propane-diol, Vitamin E, nicatinamide,stearyl alcohol, isopropyl palmitate, sorbitol, amino acid complexes,panthenol, allantoin, Dihydroxypropyltrimonium Chloride, quaternizedhydrolyzed protein such as collagen, oat, wheat, etc. . . . , inositol,fructose, sucrose, hydrolyzed plant proteins, seaweed extract,polyethylene glycol, ammonium lactate, sodium hyaluronate, and cyclicpeptides.

Some non-limiting examples of humectants include hydroxyethyl urea,agarose, urea, sodium PCA, arginine PCA, fructose, glucose, glutamicacid, glycerine, honey, lactose, maltose, polyethylene glycol, sorbitoland mixtures thereof.

Some non-limiting examples of occlusive agents include petrolatum, sheabutter, avocado oil, balm mint oil, cod liver oil, mineral oil,trimyristin, stearyl stearate, synthetic wax, or mixtures thereof. Somenon-limiting examples of other moisturizers include ethyl hexylglycerin,cholesterol, cystine, hyaluronic acid, keratin, lecithin, egg yolk,glycine, PPG-12, polyquaternium polymers such as polyquaternium-11,behentrimonium chloride, dihydroxypropyl PEG-5 linoleammonium chloride,glycerol oleate, PEG-7 glyceryl cocoate, cocoglucoside, PEG-200hydrogenated glyceryl palmate, panthenol, retinol, salicylic acid,vegetable oil, methyl gluceth-10, methyl gluceth-20, ethoxylatedderivatives of skin conditioners such as glycereth-26 and ethoxylatedshea butter, and mixtures thereof. Finally, some non-limiting examplesof anti-irritants include bisabolol and panthenol.

The skin conditioner component is present in lower amounts that seen intraditional commercial skin sanitizers. Applicants have found that dueto the chronic use of such sanitizers, lower amounts can be used withsimilar health benefits and less tacky residue. The skin conditioner orcombination thereof in total is present in the composition in an amountfrom about 0.1 wt. % to about 20 wt. %, preferably from about 0.5 wt. %to about 15 wt. %, and more preferably from about 1 wt. % to about 10wt. %.

Foam Boosting Copolymer

The composition of the invention includes a novel foam boosting polymer.The foam boosting polymer is present in an amount of from about 0.05 wt.% to about 18 wt. %, preferably from about 0.1 to about 10 wt. %.

Polymers which function according to the invention comprise ahydrophobically modified cationic polymer obtainable from thepolymerization of the following structural units:

-   -   (i) a first structural unit derived from one or more cationic        ethylenically unsaturated monomers;    -   (ii) a second structural unit derived from one or more        water-soluble monomers.

(i) First Structural Unit

The first structural unit is a water-soluble cationic ethylenicallyunsaturated monomer. The first structural unit can be a dialkyl diallylammonium with halides, hydrogensulfate or methosulfate as counterionsaccording to formula (I):

wherein:

-   -   R₁ and R₂ are, independently of one another, hydrogen or C₁-C₄        alkyl;    -   R₃ and R₄ are, independently of one another, hydrogen, alkyl,        hydroxyalkyl, carboxyl alkyl, carboxyamide alkyl or alkoxyalkyl        groups having from 1 to 18 carbon atoms; and    -   Y—is the counterion selected from the group consisting of        chloride, bromide, iodine or hydrogensulfate or methosulfate.

In another embodiment, the first structural unit is a quaternary or acidsalt of dialkyl amino alkyl (meth)acrylate. In a further embodiment, thefirst structural unit is an acid salt of a dialkyl amino alkyl (meth)acrylamide or a quaternary dialkyl amino alkyl (meth) acrylamideaccording to formula (II):

wherein:

-   -   R₁ is H or C₁-C₄ alkyl;    -   R₂ is H or methyl;    -   R₃ is C₁-C₄ alkylene;    -   R₄, R₅ and R₆ are each independently H or C₁-C₃₀ alkyl;    -   X is —O— or —NH—; and    -   Y is Cl; Br; I; hydrogensulfate or methosulfate.

In one embodiment of the present invention, it is preferred that, in thecationic monomer of the formula (II), wherein:

-   -   R₁ and R₂ are each H or    -   R₁ is H and R₂ is CH₃ or preferably also H.        Suitable examples of the first structural unit are diallyl        dimethyl ammonium chloride (DADMAC),        (3-acrylamidopropyl)-trimethylammonium chloride (APTAC),        (3-methacryl-amidopropyl)-trimethylammonium chloride (MAPTAC),        dimethylaminopropylacrylat methochlorid,        dimethylaminopropylmethacrylat methochlorid. Further suitable        examples of the first structural unit are        [2-(Acryloyloxy)ethyl]trimethylammonium chloride, also referred        to as dimethylaminoethyl acrylate methochloride (DMA3*MeCl), or        trimethyl-[2-(2-methylprop-2-enoyloxy)ethyl]azanium chloride,        also referred as dimethylaminoethyl methacrylate methochloride        (DMAEMA*MeCl). Preferably, the first structural unit is DADMAC.

(ii) Second Structural Unit

The second structural unit is acylamide or methacrylamide

All wt % for each of the structural units are calculated based on 100%by weight of all structural units derived from all the monomers in theco polymer. A preferred copolymer is a DADMAC/(meth)acrylamide copolymerwith a molecular weight of approximately 2,000,000 such as theMackermium 007 line of copolymers available from Rhodia, Inc.

Foam Stabilizer

The composition includes a foam solubilizer which includes an organicsolvent, other than a short chain alcohol, typically soluble in bothwater and oil. Examples of foam solubilizers according to the presentinvention include: polyols, such as glycerol (glycerin), propyleneglycol, hexylene glycol, diethylene glycol, propylene glycol n-alkanols,terpenes, di-terpenes, tri-terpenes, terpen-ols, limonene, terpene-ol,l-menthol, dioxolane, ethylene glycol, other glycols, sulfoxides, suchas dimethylsulfoxide (DMSO), dimethylformanide, methyl dodecylsulfoxide, dimethylacetamide; monooleate of ethoxylated glycerides (with8 to 10 ethylene oxide units); azone (1-dodecylazacycloheptan-2-one),2-(n-nonyl)-1,3-dioxolane; esters, such as isopropylmyristate/palmitate, ethyl acetate, butyl acetate, methyl proprionate,capric/caprylic triglycerides, octylmyristate, dodecyl-myristate;myristyl alcohol, lauryl alcohol, lauric acid, lauryl lactate ketones;amides, such as acetamide oleates such as triolein; various alkanoicacids such as caprylic acid; lactam compounds, such as azone; alkanols,such as dialkylamino acetates, and admixtures thereof. According to onepreferred embodiment the foam solubilizer is hexalene glycol.

The foam solubilizer is present in the composition in an amount of fromabout 0.1 wt. % to about 10 wt. %, preferably from about 0.5 wt. % toabout 8 wt. %.

Chelating Agent

The composition is generally a concentrate or a ready to use compositionthat includes a chelating agent. In general, a chelating agent is amolecule capable of coordinating (i.e., binding) the metal ions commonlyfound in water sources to prevent the metal ions from interfering withthe action of the other ingredients. Examples of chelating agentsinclude phosphonic acid and phosphonates, phosphates, aminocarboxylatesand their derivatives, pyrophosphates, ethylenediamine andethylenetriamine derivatives, hydroxyacids, and mono-, di-, andtri-carboxylates and their corresponding acids. In certain embodimentsthe composition is phosphate free. Preferred chelating agents formcalcium-chelating agent complexes with a stability constant (expressedin logarithmic form) of about 5.5 or greater. The calcium-chelatingagent stability constant (K) is the measure of the stability of acalcium-chelating agent complex (CaL) formed by the reaction of acalcium ion (Ca) with a chelating agent (L) in aqueous solution.

Ca+L

CaL

The stability constant is expressed as:

$K = \frac{\lbrack{CaL}\rbrack}{\lbrack{Ca}\rbrack \mspace{14mu}\lbrack L\rbrack}$

Where:

K=stability constant for the calcium-chelating agent complex[CaL]=concentration (mol/L) of the calcium-chelating agent complex[Ca]=concentration (mol/L) of calcium ions[L]=concentration (mol/L) of the chelating agentPreferred chelating agents are selected from the group comprisingethylenediaminetetraacetic acid (EDTA); diethylenetriaminepentaceticacid (DTPA); methylglycine-N,N-diacetic acid (MGDA); glutamicacid-N,N-diacetic acid (GLDA); Aspartic acid-N,N-diacetic acid (ASDA)and alkali, alkali earth metal, transition metal and/or ammonium saltsthereof.

Carriers

The carrier of the present antimicrobial composition comprises water,propylene glycol, glycerols, alcohols or mixtures thereof. It should beappreciated that the water may be provided as deionized water or assoftened water. The water provided as part of the composition can berelatively free of hardness. It is expected that the water can bedeionized to remove a portion of the dissolved solids. That is, theconcentrate can be formulated with water that includes dissolved solids,and can be formulated with water that can be characterized as hardwater.

The antimicrobial composition of the present invention does not relyupon a low pH or a high pH to provide a rapid reduction in microbialpopulations. Antimicrobial populations of the present invention have apH of about 5.0 to about 8.0. Within this pH range, the presentcompositions effectively reduce microbial populations, and are consumeracceptable, i.e., are mild to the skin, are phase stable, and generatecopious, stable foam.

Additional Functional Materials

The antimicrobial composition can include additional components oragents, such as additional functional materials. As such, in someembodiments, the antimicrobial composition including the cationic activeingredients and quaternary sugar-derived surfactants may provide a largeamount, or even all of the total weight of the antimicrobialcomposition, for example, in embodiments having few or no additionalfunctional materials disposed therein. The functional materials providedesired properties and functionalities to the antimicrobial composition.For the purpose of this application, the term “functional materials”include a material that when dispersed or dissolved in a use and/orconcentrate solution, such as an aqueous solution, provides a beneficialproperty in a particular use. The antimicrobial composition containingthe cationic active ingredients and the quaternized sugar-derivedsurfactants may optionally contain additional surfactants, pH adjustingcompound, preservatives, antioxidants, fragrances, dyes, otherdisinfectants, sanitizers, thickening or gelling agents, or mixturesthereof. Some particular examples of functional materials are discussedin more detail below, but it should be understood by those of skill inthe art and others that the particular materials discussed are given byway of example only, and that a broad variety of other functionalmaterials may be used. For example, may of the functional materialdiscussed below relate to materials used in disinfecting and/orcleansing applications, but it should be understood that otherembodiments may include functional materials for use in otherapplications.

Preservatives

The composition may optionally include a preservative. Generally,preservatives fall into specific classes including phenolics, halogencompounds, quaternary ammonium compounds, metal derivatives, amines,alkanolamines, nitro derivatives, biguanides, analides, organosulfur andsulfur-nitrogen compounds, alkyl parabens, and miscellaneous compounds.Some non-limiting examples of phenolic antimicrobial agents includepentachlorophenol, orthophenylphenol, chloroxylenol, p-chloro-m-cresol,p-chlorophenol, chlorothymol, m-cresol, o-cresol, p-cresol, isopropylcresols, mixed cresols, phenoxyethanol, phenoxyethylparaben,phenoxyisopropanol, phenyl paraben, resorcinol, and derivatives thereof.Some non-limiting examples of halogen compounds include trichlorohydroxydiphenyl ether (Triclosan), sodium trichloroisocyanurate, sodiumdichloroisocyanurate, iodine-poly(vinylpyrolidin-onen) complexes, andbromine compounds such as 2-bromo-2-nitropropane-1,3-diol, andderivatives thereof. Some non-limiting examples of quaternary ammoniumcompounds include benzalkonium chloride, benzethonium chloride,behentrimonium chloride, cetrimonium chloride, and derivatives thereof.Some non-limiting examples of amines and nitro containing compoundsinclude hexahydro-1,3,5-tris(2-hydroxyethyl)-s-triazine,dithiocarbamates such as sodium dimethyldithiocarbamate, and derivativesthereof. Some non-limiting examples of biguanides includepolyaminopropyl biguanide and chlorhexidine gluconate. Some non-limitingexamples of alkyl parabens include methyl, ethyl, propyl and butylparabens.

The preservative is preferably present in the composition in an amountfrom about 0 to about 3 wt. %, from about 0.01 to about 2 wt. %, andfrom about 0.5 to about 1 wt. %.

Thickener

The composition may optionally include a thickener. Exemplary thickenersinclude (1) cellulosic thickeners and their derivatives, (2) naturalgums, (3) starches, (4) stearates, and (5) fatty acid alcohols, (6)acrylic acid polymers and crosspolymers (example “carbomer”, (7)Aristoflex AVC (need generic category name) Some non-limiting examplesof cellulosic thickeners include carboxymethyl hydroxyethylcellulose,cellulose, hydroxybutyl methylcellulose, hydroxyethylcellulose,hydroxypropylcellulose, hydroxypropyl methyl cellulose, methylcellulose,microcrystalline cellulose, sodium cellulose sulfate, and the like. Somenon-limiting examples of natural gums include acacia, calciumcarrageenan, guar, gelatin, guar gum, hydroxypropyl guar, karaya gum,kelp, locust bean gum, pectin, sodium carrageenan, tragacanth gum,xanthan gum, and the like. Some non-limiting examples of starchesinclude oat flour, potato starch, wheat flour, wheat starch, and thelike. Some non-limiting examples of stearates include PEG-150distearate, methoxy PEG-22/dodecyl glycol copolymer, and the like. Somenon-limiting examples of fatty acid alcohols include caprylic alcohol,cetearyl alcohol, lauryl alcohol, oleyl alcohol, palm kernel alcohol,and the like.

The amount of thickener in the composition depends on the desiredviscosity of the composition.

Additional Surfactants

The composition may optionally contain additional surfactant orcombination of surfactants. These can be selected from water soluble orwater dispersible nonionic, semi-polar nonionic, cationic, amphoteric,or surface-active agents; or any combination thereof. The particularsurfactant or surfactant mixture chosen for use in the process andproducts of this invention can depend on the conditions of finalutility, including method of manufacture, physical product form, use pH,and the like. The composition is substantially free of anionic orzwitteronic surfactants.

A typical listing of the classes and species of surfactants usefulherein appears in U.S. Pat. No. 3,664,961 issued May 23, 1972, toNorris. The disclosure of which is hereby incorporated by reference.Additional surfactants, if present may be in the amount of from 0.5 toabout 10 wt. %, from about 1.0 to about 7 wt. % and from about 2 toabout 5 wt. %.

pH-Adjusting Compound

Sanitizer compositions of the present invention have a pH of about 4.0to about 8. Within this pH range, the present compositions effectivelyreduce microbial populations, and are consumer acceptable, i.e., aremild to the skin, are phase stable, and generate copious, stable foam.In some instances a pH adjusting compound may be necessary in asufficient amount to provide a desired composition pH. To achieve thefull advantage of the present invention, the pH-adjusting compound ispresent in an amount of about 0.05% to about 3.5%, by weight.

Examples of basic pH-adjusting compounds include, but are not limitedto, ammonia; mono-, di-, and trialkyl amines; mono-, di-, andtrialkanolamines; alkali metal and alkaline earth metal hydroxides;alkali metal phosphates; alkali sulfates; alkali metal carbonates; andmixtures thereof. However, the identity of the basic pH adjuster is notlimited, and any basic pH-adjusting compound known in the art can beused. Specific, nonlimiting examples of basic pH-adjusting compounds areammonia; sodium, potassium, and lithium hydroxide; sodium and potassiumphosphates, including hydrogen and dihydrogen phosphates; sodium andpotassium carbonate and bicarbonate; sodium and potassium sulfate andbisulfate; monoethanolamine; trimethylamine; isopropanolamine;diethanolamine; and triethanolamine.

The identity of an acidic pH-adjusting compound is not limited and anyacidic pH-adjusting compound known in the art, alone or in combination,can be used. Examples of specific acidic pH-adjusting compounds are themineral acids and polycarboxylic acids. Nonlimiting examples of mineralacids are hydrochloric acid, nitric acid, phosphoric acid, and sulfuricacid. Nonlimiting examples of polycarboxylic acids are citric acid,glycolic acid, and lactic acid.

Antioxidant

The composition may optionally include an antioxidant for improved skincondition through the removal of free radicals, and improved productstability. Some non-limiting examples of antioxidants include retinoland retinol derivatives, ascorbic acid and ascorbic acid derivatives,BHA, BHT, beta carotene, cysteine, erythorbic acid, hydroquinone,tocopherol and tocopherol derivatives, and the like.

If an antioxidant is included, it is preferably present in thecomposition in an amount from about 0.001 to about 2 wt. %, from about0.01 to about 1 wt. %, and from about 0.05 to about 0.5 wt. %.

Fragrance

The composition may optionally include a fragrance. Examples of possiblefragrances include, but are not limited to natural oils or naturallyderived materials, and synthetic fragrances such as hydrocarbons,alcohols, aldehydes, ketones, esters, lactones, ethers, nitriles, andpolyfunctionals. Non-limiting examples of natural oils include thefollowing: basil (Ocimum basilicum) oil, bay (Pimento acris) oil, beebalm (Monarda didyma) oil, bergamot (Citrus aurantium bergamia) oil,cardamom (Elettaria cardamomum) oil, cedarwood (Cedrus atlantica) oil,chamomile (Anthemis nobilis) oil, cinnamon (Cinnamomum cassia) oil,citronella (Cymbopogon nardus) oil, clary (Salvia sclarea) oil, clove(Eugenia caryophyllus) oil, cloveleaf (Eufenia caryophyllus) oil,Cyperus esculentus oil, cypress (Cupressus sempervirens) oil, Eucalyptuscitriodora oil, geranium maculatum oil, ginger (Zingiber officinale)oil, grapefruit (Citrus grandis) oil, hazel (Corylus avellana) nut oil,jasmine (Jasminum officinale) oil, Juniperus communis oil, Juniperusoxycedrus tar, Juniperus virginiana oil, kiwi (Actinidia chinensis)water, lavandin (Lavandula hybrida) oil, lavender (Lavandulaangustifolia) oil, lavender (Lavandula angustifolia) water, lemon(Citrus medica limonum) oil, lemongrass (Cymbopogon schoenanthus) oil,lime (Citrus aurantifolia) oil, linden (Tilia cordata) oil, linden(Tilia cordata) water, mandarin orange (Citrus nobilis) oil, nutmeg(Myristica fragrans) oil, orange (Citrus aurantium dulcis) flower oil,orange (Citrus aurantium dulcis) oil, orange (Citrus aurantium dulcis)water, patchouli (Pogostemon cablin) oil, peppermint (Menthe piperita)oil, peppermint (Menthe peperita) water, rosemary (Rosmarinusofficinalis) oil, rose oil, rose (Rosa damascena) extract, rose (Rosamultiflora) extract, rosewood (Aniba rosaeodora) extract, sage (Salviaofficinalis) oil, sandalwood (Santalum album) oil, spearmint (Mentheviridis) oil, tea tree (Melaleuca alternifolia) oil, and ylang ylang(Cananga odorata) oil. Some non-limiting examples of synthetichydrocarbon fragrances include caryophyllene, β-farnesene, limonene,α-pinene, and β-pinene. Some non-limiting examples of synthetic alcoholfragrances include bacdanol, citronellol, linalool, phenethyl alcohol,and α-terpineol (R═H). Some non-limiting examples of synthetic aldehydefragrances include 2-methyl undecanal, citral, hexyl cinnamic aldehyde,isocycolcitral, lilial, and 10-undecenal. Some non-limiting examples ofsynthetic ketone fragrances include cashmeran, α-ionone, isocyclemone E,koavone, muscone, and tonalide. Some non-limiting examples of syntheticester fragrances include benzyl acetate, 4-t-butylcyclohexyl acetate(cis and trans), cedryl acetate, cyclacet, isobornyl acetate, andα-terpinyl acetate (R=acetyl). Some non-limiting examples of syntheticlactone fragrances include coumarin, jasmine lactone, muskalactone, andpeach aldehyde. Some non-limiting examples of synthetic ether fragrancesinclude ambroxan, anther, and galaxolide. Some non-limiting examples ofsynthetic nitrile fragrances include cinnamonitrile and gernonitrile.Finally, some non-limiting examples of synthetic polyfunctionalfragrances include amyl salicylate, isoeugenol, hedione, heliotropine,lyral, and vanillin.

The composition may include a mixture of fragrances including a mixtureof natural and synthetic fragrances. The fragrance can be present in acomposition in an amount up to about 5 wt. %, preferably from 0 to about3 wt. %, from about 0 to about 1 wt. %, and from about 0 to about 0.2wt. %.

Dye

The composition may optionally include a dye. Examples of dyes includeany water soluble or product soluble dye, any FD&C or D&C approved dye.

Methods of Making the Compositions

The compositions of to the invention are easily produced by any of anumber of known art techniques. Conveniently, a part of the water issupplied to a suitable mixing vessel further provided with a stirrer oragitator, and while stirring, the remaining constituents are added tothe mixing vessel, including any final amount of water needed to provideto 100% wt. of the inventive composition.

The compositions may be packaged in any suitable container particularlyflasks or bottles, including squeeze-type or pump bottles, as well asbottles provided with a spray apparatus (e.g. trigger spray) which isused to dispense the composition by spraying. The selected packaging mayhave a pump head foamer. Examples of commercially available pump headfoamers include the F2 foamer from Rexam PLC (London, England, formerlyAirspray), and the RF-17 Palm Foamer from Rieke Corporation (Auburn,Ind.). Accordingly the compositions are desirably provided asconcentrates or ready to use products in a manual or automateddispensing equipment.

The composition may be provided in various packaging sizes. Examples ofpackaging sizes include 1.5 oz, 500 ml and 1 liter bottles.

Whereas the compositions of the present invention are intended to beused in the types of liquid forms described, nothing in thisspecification shall be understood as to limit the use of the compositionaccording to the invention with a further amount of water to form asolution there from. Conversely, nothing in the specification shall bealso understood to limit the forming of a “super-concentrated”composition based upon the composition described above Such asuper-concentrated ingredient composition is essentially the same as thecompositions described above except in that they include a lesser amountof water.

Methods Employing the Compositions

The invention includes compositions and methods for reducing thepopulation of a microorganism on skin, a method for treating a diseaseof skin, and the like. These compositions and methods can operate bycontacting the body with a composition of the invention. Contacting caninclude any of numerous methods for applying a composition of theinvention, such as spraying the compositions, immersing, foam or geltreating the skin with the composition, or a combination thereof. Thecompositions and methods may be used without further dilution with wateror other suitable diluents or may be supplied as concentratedcompositions. The concentrated compositions may be diluted prior topackaging or diluted prior to/at the point of use The concentratedcompositions may be diluted at a concentrate:diluent ratio from about1:1 to about 1:10. More preferably, the concentrated compositions may bediluted at a concentrate:diluent ration from about 1:3 to about 1:8. Theconcentrated compositions may be diluted manually or through automateddispensing and/or diluting equipment.

The compositions of the invention may be combined with treated oruntreated water. For example, the compositions may be combined withaerated, chlorinated, desalinated, disinfected, reverse osmosis (RO)and/or filtered water. The compositions may also be combined with watersources containing mineral ions such as, but not limited to calcium,magnesium, iron, copper, manganese, bicarbonate, phosphate, silicate,sulfate, fluoride, chloride, bromide, hydroxide, nitrate, nitrite andthe like. Additionally the concentrate compositions may be diluted at orprior to the point of use with water pretreated with coagulant and/orflocculants.

The compositions of the invention can be included in any skinapplication products such, sanitizers, deodorizers, antiseptics,fungicides, germicides, virucides, waterless hand sanitizers, and pre-or post-surgical scrubs, preoperative skin preps.

Embodiments of the Present Invention

The antimicrobial composition of the present invention has a high broadspectrum of antimicrobial efficacy, high foam and reduced irritation tomammalian tissue. Exemplary compositions are provided in the followingtables.

TABLE A Antimicrobial Composition with improved Foam Stability(Expressed as Weight Percentage) Antimicrobial composition (pH 5.0-6.7)Preferred More Preferred Embodiment Embodiment (% w/w) (% w/w) LowerUpper Lower Upper Ingredient Example Limit Limit Limit Limit CationicQuaternary 0.4 1.5 0.5 1.0 Active Ammonium Ingredient Compound (QAC)[Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC)] Quaternized Quaternary0.1 4.5 0.25 2.5 Sugar-Derived functionalized Surfactant alkylpolyglucoside or Polyquaternary functionalized alkyl polyglucoside FoamBoosting Dimethyl amine 0.1 12.0 1.0 5.0 Surfactant oxide; alkylpolyglucoside Adjuvants Glycerin, 1.0 30.0 5.0 25.0 (Dermal) Sorbitol,Esters, Polyquats, Glycols, Foam DADMAC/ 0.05 18.0 0.1 10 Stabilizingacrylamide Polymer Foam Hexylene glycol 0.1 10.0 0.5 8 SolubilizerChelating EDTA 0.1 10.0 0.5 8 agent

Antimicrobial Dermal Cleanser

TABLE 2 Antimicrobial Dermal Wash Exemplary Composition (Expressed asWeight Ratio) Antimicrobial Dermal Wash (pH 5.0-6.7) Preferred MostPreferred Embodiment Embodiment (Weight Ratio) (Weight Ratio) LowerUpper Lower Upper Ingredient Example Limit Limit Limit Limit CationicQuaternary 1.0 1.0 1.0 1.0 Active Ammonium Ingredient Compound (QAC)[Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC)] Quaternized Quaternary0.25 3.0 0.5 2.5 Sugar-Derived functionalized Surfactant alkylpolyglucoside or Polyquaternary functionalized alkyl polyglucoside FoamBoosting Dimethyl amine 0.25 8.0 2.0 5.0 Surfactant oxide; alkylpolyglucoside Adjuvants Glycerin, 2.5 16.0 4.0 10.0 (Dermal) Sorbitol,Esters, Polyquats, Preservative

TABLE 3 Dermal Cleanser Exemplary Composition (Expressed as WeightPercentage) Dermal Cleanser (pH 5.5-7.5) Preferred Most PreferredEmbodiment Embodiment (% w/w) (% w/w) Lower Upper Lower Upper IngredientExample Limit Limit Limit Limit Cationic Quaternary 0.3 5.0 0.5 4.0Active Ammonium Ingredient Compound (QAC) [Alkyl Dimethyl BenzylAmmonium Chloride (ADBAC)] Quaternized Quaternary 0.1 15.0 0.25 10.0Sugar-Derived functionalized Surfactant alkyl polyglucoside orPolyquaternary functionalized alkyl polyglucoside Foam Boosting Dimethyl0.1 40.0 2.0 20.0 Surfactant amine oxide; alkyl polyglucoside AdjuvantsGlycerin, 1.0 25.0 1.75 15.0 (Dermal) Sorbitol, Esters, Polyquats,Preservative

TABLE 4 Dermal Cleanser Exemplary Composition (Expressed as WeightRatio) Dermal Cleanser (pH 5.5-7.5) Preferred Most Preferred EmbodimentEmbodiment (% w/w) (% w/w) Lower Upper Lower Upper Ingredient ExampleLimit Limit Limit Limit Cationic Quaternary 1.0 1.0 1.0 1.0 ActiveAmmonium Ingredient Compound (QAC) [Alkyl Dimethyl Benzyl AmmoniumChloride (ADBAC)] Quaternized Quaternary 0.3 3.0 0.5 2.5 Sugar-Derivedfunctionalized Surfactant alkyl polyglucoside or Polyquaternaryfunctionalized alkyl polyglucoside Foam Boosting Dimethyl amine 0.3 8.01.0 5.0 Surfactant oxide; alkyl polyglucoside Adjuvants Glycerin, 3.35.0 3.5 3.75 (Dermal) Sorbitol, Esters, Polyquats, Preservative

TABLE 5 Surgical Scrub Exemplary Composition (Expressed as WeightPercentage) Surgical Scrub (pH 5.5-7.5) Preferred Most PreferredEmbodiment Embodiment (% w/w) (% w/w) Lower Upper Lower Upper IngredientExample Limit Limit Limit Limit Cationic Chlorhexidine 1 6.0 1.5 5.0Active Gluconate Ingredient (CHG) Quaternized Quaternary 0.2 18.0 0.612.5 Sugar-Derived functionalized Surfactant alkyl polyglucoside orPolyquaternary functionalized alkyl polyglucoside Foam Boosting Dimethylamine 0.2 36.0 1.5 25.0 Surfactant oxide; alkyl polyglucoside AdjuvantsGlycerin, 1.0 25.0 2.0 10.0 (Dermal) Sorbitol, Esters, Polyquats,Preservative

TABLE 6 Surgical Scrub Exemplary Composition (Expressed as Weight Ratio)Surgical Scrub (pH 5.5-7.5) Preferred Most Preferred EmbodimentEmbodiment (% w/w) (% w/w) Lower Upper Lower Upper Ingredient ExampleLimit Limit Limit Limit Cationic Chlorhexidine 1.0 1.0 1.0 1.0 ActiveGluconate Ingredient (CHG) Quaternized Quaternary 0.2 3.0 0.4 2.5Sugar-Derived functionalized Surfactant alkyl polyglucoside orPolyquaternary functionalized alkyl polyglucoside Foam Boosting Dimethylamine 0.2 6.0 1.0 5.0 Surfactant oxide; alkyl polyglucoside AdjuvantsGlycerin, 1.0 4.2 1.3 2.0 (Dermal) Sorbitol, Esters, Polyquats,Preservative

EXAMPLES

The present invention is more particularly described in the followingexamples that are intended as illustrations only, since numerousmodifications and variations within the scope of the present inventionwill be apparent to those skilled in the art. Unless otherwise noted,all parts, percentages, and ratios reported in the following examplesare on a weight basis, and all reagents used in the examples wereobtained, or are available, from the chemical suppliers described below,or may be synthesized by conventional techniques.

Materials used in the described embodiments include, but are not limitedto: Stearyldimonium-hydroxypropyl Laurylglucosides Chloride,Cocoglucosides Hydroxypropyl-trimonium Chloride, LaurylglucosidesHydroxypropyl-trimonium Chloride, Poly (Lauryldimonium-hydroxypropylDecylglucosides Chloride), Poly (Stearyldimonium-hydroxypropylDecylglucosides Chloride), Poly (Stearyldimonium-hydroxypropylLaruylglucosides Chloride), Poly (Trimonium-hydroxypropyl CocoglucosidesChloride).

The following methods were used in the preparation and testing of theexamples:

Antimicrobial and Microbial Efficacy:

-   -   (a) Determination of Time Kill Activity: The activity of        antimicrobial compositions was measured by the time kill method        [ASTM E 2315 Standard Guide for Assessment of Antimicrobial        Activity Using a Time Kill Procedure], whereby the survival of        challenged organisms exposed to an antimicrobial test        composition is deterred as a function of time. In this test, a        diluted aliquot of the composition is brought into contact with        a known population of test bacteria for a specified time period        at a specified temperature. The test composition is neutralized        at the end of the time period, which arrests the antimicrobial        activity of the composition. The percent or, alternatively, log        reduction from the original bacteria population is calculated.        In general, the time kill method is known to those skilled in        the art. In addition, comparative data on the foam profile of        representative systems is shown.    -   (b) The composition can be tested at any concentration from        0-100%. The choice of which concentration to use is at the        discretion of the investigator, and suitable concentrations are        readily determined by those skilled in the art. All testing if        performed in triplicate, the results are combined, and the        average log reduction is reported.    -   (c) The choice of contact time period also is at the discretion        of the investigator. Any contact time period can be chosen.        Typical contact times range from 15 second to 5 minutes, with 30        seconds and 1 minute being typical contact times. The contact        temperature also can be any temperature, typically room        temperature, or about 25 degrees Celsius.    -   (d) The microbial suspension, or test inoculum, is prepared by        growing a microbial culture on any appropriate solid media        (e.g., agar). The microbial population then is washed from the        agar with sterile physiological saline and the population of the        microbial suspension is adjusted to about 10⁸ colony forming        units per ml (cfu/ml).    -   (e) The table below lists the test microbial cultures used in        the following tests and includes the name of the bacteria, the        ATCC (American Type Culture Collection) identification number,        and the abbreviation for the name of the organism used        hereafter.

Organism Name ATCC # Abbreviation S. aureusylococcus 6538 S. aureusEscherichia coli 112229 E. coli

S. aureus is a Gram positive bacteria, whereas, E. coli is a Gramnegative bacteria.

The log reduction is calculated using the formula:

Log reduction=log₁₀(numbers control)−log₁₀(test sample survivors).

Foam Height Determination

The foam height was determined with the following procedural steps:

1. Prepare a 1% solution of the product in 5 grain water.

2. Pour 150 mL of the solution into a blender

3. Mix on medium speed 10 seconds.

4. Pour into a 1000 mL beaker and measure foam height.

5. Measure foam height at 3 and 5 minutes.

Foam Stability Determination

The foam stability was determined by using the difference between thefoam/air interference and the foam/aqueous interface 5 minutes afterpouring a 1% solution into a 1000 mL beaker.

In Vitro Irritancy Determination

In vitro irritancy was assessed by an external testing facility usingMatek Corporation's “EpiDerm MTT ET-50 Protocol (EPI-200)”.

The test consists of a topical exposure of the neat test chemical to areconstructed human epidermis (RhE) model followed by a cell viabilitytest. Cell viability is measured by dehydrogenase conversion of MTT[(3-4,5-dimethyl thiazole 2-yl) 2,5-diphenyltetrazolium bromide],present in cell mitochondria, into a blue formazan salt that isquantitatively measured after extraction from tissues. The reduction ofthe viability of tissues exposed to chemicals in comparison to negativecontrols (treated with water) is used to predict the skin irritationpotential.

EpiDerm tissues are conditioned by incubation of releasetransport-stress related compounds and debris overnight. Afterpre-incubation, tissues are topically exposed to the test chemicals for60 minutes. Preferably, three tissues are used per test chemical (TC)and for the positive control (PC) and negative control (NC). Tissues arethen thoroughly rinsed, blotted to remove the test substances, andtransferred to fresh medium. Tissues are incubated for 42 hrs.Afterwards, the MTT assay is performed by transferring the tissues to24-well plates containing MTT medium (1 mg/mL) after a 3 hr MTTincubation, the blue formazan salt formed by cellular mitochondria isextracted with 2.0 mL/tissue of isopropanol and the optical density ofthe extracted formazan is determined using a spectrophotometer at 570nm. Relative cell viability is calculated for each tissue as % of themean of the negative control tissues. Skin irritation potential of thetest material is predicted if the remaining relative cell viability isbelow 50%.

Foam Resistance Determination

The foam resistance was determined by measuring 65 grams of the testproduct into a blender and blending for about 10 seconds on mediumspeed. Thereafter, the test solution was poured into a cylinder and aplastic ball was dropped into the test solution and timed to determinehow many seconds it took for the plastic ball to drop from a firstpre-determined level to a second pre-determined level, e.g., from 100 mLmark on the cylinder to the 40 mL mark on the cylinder.

Example 1

The following Figures demonstrate efficacy data of the presentantimicrobial composition, using various cationic active ingredients,quaternary sugar-derived surfactants and optional foam boostingsurfactants.

Table 7 and FIG. 1 (Log Kill of Cationic Active Ingredients):

The following figures illustrate the efficacy following a 30 secondexposure time of three different cationic active ingredients,specifically, 0.5% Quat (Benzalkonium Chloride), 2% CHG (ChlorhexidineGluconate), and 1% PHMB (polyhexamethylene biguanide) in arepresentative surfactant system.

Table 7 illustrates the formulas for the three cationic activeingredient systems tested. Both the quaternary sugar-derived surfactantand foam boosting surfactant were held constant and only the cationicactive ingredient was changed between the three tests performed. Theresults are illustrated in FIG. 1.

TABLE 7 Active Ingredient Level System Ingredients (% w/w) QuaternaryActive Ingredient 0.5 Ammonium Quaternized Sugar-Derived Surfactant 1.25Compound (Quat) Foam Boosting Agent 1.95 Chlorhexidine Active Ingredient2.0 Gluconate (CHG) Quaternized Sugar-Derived Surfactant 1.25 FoamBoosting Agent 1.95 Poly Hexamethylene Active Ingredient 1.0 Biguanide(PHMB) Quaternized Sugar-Derived Surfactant 1.25 Foam Boosting Agent1.95

As illustrated in FIG. 1, all three cationic active ingredients had highcidal activity against S. aureus and E. coli bacteria within a 30 secondexposure time.

Table 8 and FIG. 2 (Log Kill of Quaternary Sugar-Derived Surfactants):

Next, Applicants tested the efficacy against S. aureus and E. colibacteria with increased concentrations of quaternary sugar-derivedsurfactants, specifically, Poly (Trimoniumhydroxypropyl CocogluocosidesChloride). The amount and type of cationic active ingredient (0.5% ADBACQuat) and foam boosting surfactant (1.95% Alkyl Dimethyl Amine Oxide)was held constant. Table 8 below illustrates the quantitative results ofthis test and FIG. 2 illustrates the graphical results.

TABLE 8 Quaternized Foam Sugar-Derived Active Boosting SurfactantIngredient Agent S. aureus Log E. coli Log (% w/w) (% w/w) (% w/w)Reduction Reduction 0.3 0.5 1.95 >5.0 >5.0 1.3 0.5 1.95 >5.0 >5.0 2.50.5 1.95 3.2 >5.0

As Table 8 and FIG. 2 illustrate, the quaternary sugar-derivedsurfactant has a high cidal activity against S. aureus and E. colibacteria after only 30 seconds of exposure. Also, the tolerance of thequaternary sugar derived surfactant against bacteria is shown.Furthermore, it is clearly illustrated that an increased concentrationof quaternary sugar-derived surfactant maintains a good log kill ofbacteria up until a 1 to 4 ratio of quaternary sugar-derived surfactantto cationic active ingredients.

Table 9 and FIG. 3 (Log Kill of Foam Boosting Surfactants):

Table 15 and FIG. 3 illustrate the efficacy with increasedconcentrations of foam boosting surfactants, specifically, amine oxide.The amount and type of cationic active ingredient (0.5% ADBAC Quat) andQuaternary sugar-derived surfactant (1.25% Poly TrimoniumhydroxypropylCocoglucosides Chloride) were held constant. Table 9 below illustratesthe quantitative results of this test and FIG. 3 illustrates thegraphical results.

TABLE 9 Foam Quaternized Boosting Sugar-Derived Agent Active SurfactantS. aureus Log E. coli Log (% w/w) (% w/w) (% w/w) Reduction Reduction1.95 0.5 1.25 >5.5 >5.5 3.0 0.5 1.25 >5.5 >5.5 4.2 0.5 1.25 >5.5 >5.5

As Table 9 and FIG. 3 illustrate, the foam boosting surfactant has ahigh cidal activity against S. aureus and E. coli bacteria after only 30seconds of exposure. Also, the tolerance of the foam boosting surfactantagainst bacteria is shown. Furthermore, it is clearly illustrated that abroad range of foam boosting surfactant maintains a good log kill ofbacteria.

FIG. 4 (Mildness Index for an Antimicrobial Dermal Cleanser Embodiment):

Applicants tested the dermal irritancy (mildness) of the preferredembodiment for an antimicrobial Dermal Cleanser as illustrated in Table12 to four commercially available antimicrobial soaps. CommerciallyAvailable Products A, C and D are available by Gojo Medicated, Akron,Ohio and Commercially Available Product B is available by Dial asubsidiary of Henkel Corporation, Dusseldorf, Germany. As illustrated inFIG. 4, the antimicrobial dermal cleanser of the current invention has ahigh relative mildness index especially in comparison to antimicrobialhand soaps that are commercially available.

FIG. 5 (Foam Profile for an Antimicrobial Dermal Cleanser Embodiment):

Applicants tested the foam profile of the preferred embodiment for anantimicrobial Dermal Cleanser as illustrated in Table 12 to threecommercially available antimicrobial soaps. As illustrated in FIG. 6,the antimicrobial dermal cleanser of the current invention has both goodfoam volume and foam stability especially in comparison to antimicrobialhand soaps that are commercially available.

Table 10 and FIG. 6 (Efficacy of Cationic Actives in Combination withQuaternary Sugar Derived Surfactants and Alkyl Dimethyl Amine Oxide):

Applicants tested the efficacy against S. aureus and E. coli bacteriawith various quaternary sugar-derived surfactants, held constant at1.25%. The amount and type of cationic active ingredient (0.5% ADBACQuat) and foam boosting surfactant (1.95% Alkyl Dimethyl Amine Oxide)was held constant.

TABLE 10 Quaternized Foam Sugar-Derived Active Boosting S. aureus E.coli Surfactant Ingredient Surfactant Log Log (1.25% w/w) (% w/w) (%w/w) Reduction Reduction (L8610) 0.5 1.95 >5.0 >5.0 Lauridimonium-hydroxypropyl Cocoglucosides Chloride (L1210) 0.5 1.95 >5.0 >5.0Lauridimonium- hydroxypropyl Laurylglucosides Chloride (S1218) 0.51.95 >5.0 >5.0 Stearyldimonium- hydroxypropyl Laurylglucosides Chloride(TM8610) 0.5 1.95 >5.0 >5.0 Cocoglucosides Hydroxypropyl- trimoniumChloride (TM1212) 0.5 1.95 >5.0 >5.0 Laurylglucosides Hydroxypropyl-trimonium Chloride (L1010P) 0.5 1.95 >5.0 >5.0 Poly (Lauryldimonium-hydroxypropyl Decylglucosides Chloride) (S1010P) 0.5 1.95 >5.0 >5.0 Poly(Stearyldimonium- hydroxypropyl Decylglucosides Chloride) (S1210P) 0.51.95 >5.0 >5.0 Poly (Stearyldimonium- hydroxypropyl LaruylglucosidesChloride) (TM8610P) 0.5 1.95 >5.0 >5.0 Poly (Trimonium- hydroxypropylCocoglucosides Chloride)

As Table 10 illustrates, a high log kill is maintained against S. aureusand E. coli bacteria for both quaternized sugar-derived surfactants andpolyquaternized sugar-derived surfactants. The chain length of the sugarquaternary surfactant may be altered and yet still maintain highefficacy. The graphical results of the test are illustrated in FIG. 6.

Table 11 and FIG. 7 (Comparative Foam Rigidity):

Applicants tested the foam rigidity of an embodiment of the currentinvention for use in dermal applications as shown below in Table 11 incomparison to two commercially available products, Commercial Products Eand F. Commercial Products E and F are traditional anionic surfactantbase dermal washes containing a cationic active. Commercial Product E iscommercially available by Proctor & Gamble, Cincinnati, Ohio andCommercial Product F is commercially available by Deb Group Limited,United Kingdom, England. The results of the foam rigidity test areillustrated in FIG. 7. As illustrated in FIG. 7, the foam rigidity ofthe dermal wash of the current invention is greater than commerciallyavailable cationic active dermal washes with a traditional anionicsurfactant base.

Foam Rigidity Formula of Current Invention (pH of 5.5-7.5):

TABLE 11 Weight Component Percent Water 91.7 Cationic Active (QuaternaryAmmonium Compound) 0.5 Quaternized Sugar-Derived Surfactant 0.7 FoamBoosting Surfactant 4.1 Dermal Adjuvants 3.0

Table 12 (Antimicrobial Efficacy of a Dermal Cleanser of the CurrentInvention):

Applicants tested the efficacy of the dermal cleanser of the currentinvention by determining the log reduction of both gram positive andgram negative bacterial after 30 seconds of exposure.

Dermal Cleanser of Current Invention (pH of 5.5-7.5):

TABLE 12 Weight Percent Component Range Water   7.5-99.3 Cationic Active(Quaternary Ammonium Compound) 0.3-5 Quaternized Sugar-DerivedSurfactant  0.05-7.5 Foam Boosting Surfactant 0.2-5 Dermal Adjuvants0.1-7

Table 13 (Antimicrobial Efficacy of a Surgical Scrub of the CurrentInvention):

Applicants tested the efficacy of the surgical scrub of the currentinvention by determining the log reduction of both gram positive andgram negative bacterial after 30 seconds of exposure.

Surgical Scrub of Current Invention (pH of 5.5-7.5):

TABLE 13 Weight Percent Component Range Water  56-97.8 Cationic Active(Quaternary Ammonium Compound)  1-6 Quaternized Sugar-Derived Surfactant0.2-8  Foam Boosting Surfactant 0.5-10 Dermal Adjuvants 0.5-20

Example 2 Mackernium 007S—DADMAC/Acrylamide Copolymer (Rhodia) UniquatQAC50—Benzalkonium Chloride (Lonza)

Dissolvine 100S—Ethylenediamine Tetraacetic acid sodium salt (AkzoNobel)Barlox 12—N-Alkyl (C12-16) dimethyl amine oxide (Lonza)Cola Lipid C—Cocamidopropyl PG dimonium chlorophosphate (ColonialChemical)

PolySugaQuat TM8610P—Polyquaternium 77 (Colonial Chemical) GlucamE20—Methyl Gluceth 20 (Lubrizol) Cetiol HE—PEG-7 Glyceryl Cocoate(Cognis) Ritasol SP 1005—PEG-12 Dimethicone (Rita Corporation) HestG-18-O—Glycereth-18 Ethylhexanoate (Global Seven) Kathon CG—MethylIsothiazolinone (DOW Chemical)

TABLE 14 Example Example #1 #2 USP Water 74.4 73.7 Acrylamide/DADMACCopolymer 0.6 0.59 Benzalkonium Chloride, 50% 2.5 2.4 TetrasodiumEthylenediaminetetraacetic acid, 0 0.99 40% Lauryl Dimethylamine Oxide,30% 21.8 21.6 Lactic Acid 0.69 0.69 Total 100 100

TABLE 15 Example #3 USP Water 56.91 Acrylamide/DADMAC Copolymer 0.48Benzalkonium Chloride, 50% 1.98 Tetrasodium Ethylenediaminetetraaceticacid, 40% 0.80 Lauryl Dimethylamine Oxide, 30% 17.58 Polyquaterium 773.42 Hexylene Glycol 3.00 Other functional components, fragrance, dermal15.83 adjuvants, pH adjuster, preservative Total 100

-   All samples were prepared using a 20% solution of examples 1-5    (tables 14-16) diluted in deionized water or 10 grain hardness water    as indicated. The samples were then adjusted to the appropriate pH    using lactic acid.-   The results are shown in tables 16 and 17. The results of table 17    are depicted graphically in FIG. 8.

TABLE 16 Log Reduction Water Staph. Aureus E. Coli Formulation HardnessATCC 6538 ATCC 112229 Example #1 DI Water >5.70 >5.80 Example #2 DIWater >5.70 >5.80

TABLE 17 Exposure Log Reduction Formula water Time RTU pH Staph E coliExample #3 DI 30 sec 5.81 >5.72 >5.46 Example #3 DI 30 sec5.99 >5.72 >5.46 Example #3 DI 30 sec 6.19 >5.72 >5.46 Example #3 DI 30sec 6.39 >5.72 >5.46 Example #3 DI 30 sec 6.62 >5.72 >5.46 Example #3 DI30 sec 6.8 >5.72 >5.46From table 16, one can see that the addition of chelating agent inexample 2 allows for identical antimicrobial activity in hard water.From table 17 one can see that the ready to use composition of theinvention demonstrates stable antimicrobial activity across various pHdifferences.Comparison of Chelating Agents Iminodisuccinic Acid (IDS) andEthylenediamine Tetraacetic Acid (EDTA) at pH=6.4The antimicrobial compositions of the invention where made with the samecomponents with the exception of the two different chelating agents asindicated below in Table 18.

TABLE 18 Example Example Raw Material #4 #5 USP Water 56.97 56.97 LaurylDimethylamine Oxide 30% 17.58 17.58 Polyquaternium 7 (acrylamide/DADMAC0.48 0.48 copolymer) Benzalkonium Chloride, 50% 1.98 1.98 Tetrasodiumethylenediaminetetraacetate, 0.00 1.00 40% Sodium IDS, 34% 1.17 0.00Polyquaternium 77 3.42 3.42 Hexylene Glycol 3.0 3.0 Other functionalcomponents, fragrance, dermal 15.4 15.57 adjuvants, pH adjuster Total100.00 100.00The results are shown in Table 19.

TABLE 19 Log Reduction Water Staph. Aureus E. Coli Formulation HardnessATCC 6538 ATCC 112229 Example #4 10 grain >4.90 NDR* Example #5 10grain >4.90 >5.65 *No Detectable ReductionThe testing results indicate that antimicrobial efficacy is enhanced bychelating agents with high stability constants for Ca²⁺ and Mg²⁺.Log Stability constant for IDS

Ca²⁺=5.2

Log Stability constants for EDTA

Ca²⁺=10.7 Additional Exemplary Formulations

Exam- Exam- ple 6 ple 7 USP Water 74.4 73.7 Acrylamide/DADMAC Copolymer0.6 0.59 Benzethonium Chloride, 99.5% 1.2 0 Chlorhexidene GluconatePowder, 99% 0 1.2 Tetrasodium Ethylenediaminetetraacetic acid, 40% 00.99 Lauryl Dimethylamine Oxide, 30% 21.8 21.6 Lactic Acid 0.69 0.69Total 100 100 Exam- Exam- Exam- Exam- ple 8 ple 9 ple 10 ple 11 Wt % Wt% Wt % Wt % USP Water qs qs qs qs Acrylamide/DADMAC Copolymer 0.3-0.50.3-0.5 0.3-0.5 0.3-0.5 Benzethonium Chloride, 99%   0.5 2 0 0Chlorhexidine Gluconate Salt, 20% 0 0   2.5 10  TetrasodiumEthylenediaminetetra- 0.5-1.0 0.5-1.0 0.5-1.0 0.5-1.0 acetic acid, 40%Lauryl Dimethylamine Oxide, 30% 15-20 15-20 15-20 15-20 CocamidopropylPG dimonium 4-7 4-7 4-7 4-7 chlorophosphate, 50% Polyquaterium 77 3-43-4 3-4 3-4 Glycerine, 99.5% USP 4-5 4-5 4-5 4-5 Methyl Gluceth 20 1-21-2 1-2 1-2 PEG-7 Glyceryl Cocoate 1-2 1-2 1-2 1-2 PEG-12 Dimethicone0.1-0.4 0.1-0.4 0.1-0.4 0.1-0.4 Glycereth-18 Ethylhexanoate 0.1-0.40.1-0.4 0.1-0.4 0.1-0.4 RED #33 0.1% solution 1 1 1 1 Citrus Fragranceqs qs qs qs Hexylene Glycol 2-4 2-4 2-4 2-4 Kathon CG 0.1-0.2 0.1-0.20.1-0.2 0.1-0.2 Lactic Acid qs qs qs qs Total 100 100 100 100

The above samples were made and tested in Examples 1 and 2.

The antimicrobial compositions of the present invention have severalpractical end uses, including hand cleansers, surgical scrubs, handsanitizer gels, and similar personal care products. Additional types ofcompositions include foamed compositions, such as creams, mousses, andthe like. The present antimicrobial compositions can be manufactured asdilute ready-to-use compositions, or as concentrates that are dilutedprior to or at the point of use. The dilution may occur manually or viaautomated dispensing and/or diluting equipment.

Obviously, many modifications and variations of the invention ashereinbefore set forth can be made without departing from the spirit andscope thereof, and, therefore, only such limitations should be imposedas are indicated by the appended claims.

What is claimed:
 1. An antimicrobial dermal concentrate comprising: (a)a cationic active ingredient, wherein the cationic active ingredient isan inorganic salt of an aromatic quaternary ammonium containingcompound; (b) a foam boosting surfactant; (c) from about 0.05 wt. % toabout 18 wt. % of a foam boosting copolymer; (d) a foam stabilizing,linear or branched C₅₋₁₂ diol with the structure

 Wherein R₁═H, CH₃, CH₂CH₃, CH₂CH₂CH₃, C(CH₃)₃, CH(CH₃)₂ or combinationsthereof and R₂ is a branched or linear C₁-C₉ alkyl chain; (e) anaminocarboxylate chelating agent capable of forming a calcium-chelatingagent complex with a stability constant (expressed logarithmically) of5.5 or greater; and (f) water, wherein said dermal concentrate issubstantially free of anionic surfactants, triclosan, and C₁₋₄ alcohols.2. The antimicrobial dermal concentrate of claim 1, wherein the dermalconcentrate comprises about 0.1 wt. % to about 10 wt. % of at least onecationic active ingredient.
 3. The antimicrobial dermal concentrate ofclaim 1, wherein the cationic active ingredient is selected from thegroup comprising of: alkyl dimethyl benzyl ammonium chloride (ADBAC),alkyl dimethyl ethylbenzyl ammonium chloride, and benzethonium chloride.4. The antimicrobial dermal concentrate of claim 1, wherein theantimicrobial dermal concentrate comprises about 0.05 wt. % to about 12wt. % foam boosting surfactants.
 5. The antimicrobial dermal concentrateof claim 1, wherein the foam boosting surfactant comprises a quaternizedalkyl polyglucoside, a polyquaternized alkyl polyglucoside, an alkylamine oxide, alkyl ether amine oxide, and polyethoxylated glycerolesters, or a combination thereof.
 6. The antimicrobial dermalconcentrate of claim 1, wherein the foam boosting surfactant comprisesan alkyl amine oxide or an alkyl ether amine oxide.
 7. The antimicrobialdermal concentrate of claim 1, wherein the foam boosting polymer is adimethyldiallylammonium chloride-acrylamide copolymer.
 8. The polymer ofclaim 7 wherein dimethyldiallylammonium chloride-acrylamide copolymerhas a molecular weight from about 500,000 to about 5,000,000 g/mol. 9.The antimicrobial concentrate of claim 1 wherein said a foam stabilizeris a linear or branched C₅₋₁₂ diol with the structure

wherein R═H, CH₃, CH₂CH₃, CH₂CH₂CH₃, C(CH₃)₃, CH(CH₃)₂ or combinationsthereof and R₂ is a branched or linear C₁-C₉ alkyl chain.
 10. Theantimicrobial concentrate of claim 1 wherein said a foam stabilizer ishexylene glycol.
 11. The antimicrobial dermal concentrate of claim 1wherein said chelating agent is ethylenediaminetetraacetic acid (EDTA);diethylenetriaminepentaacetic acid (DTPA); methylglycine diacetic acid(MGDA), glutamic acid-N,N-diacetic acid (GLDA) asparticacid-N,N-diacetic acid (ASDA) and alkali metal and/or ammonium saltsthereof.
 12. The antimicrobial dermal concentrate of claim 1 wherein theconcentrate is diluted prior to or at the point of use to form a usesolution wherein the ratio of concentrate to water is from about 1:1 toabout 1:10.
 13. A method of reducing bacterial, microbial, fungicidal orviral population on a dermal tissue of a mammal comprising the step of:contacting the dermal tissue of a mammal with the dermal concentrate ofclaim 1 for a sufficient time to provide substantial bacterial,microbial, fungicidal or viral reduction.
 14. The method of claim 13wherein the sufficient contact time is approximately about 1 to about 60seconds.
 15. The method of claim 13 wherein the dermal concentrate isrinsed off of the dermal tissue after contact or remains on the dermaltissue after contact.
 16. The method of claim 13 wherein the dermalconcentrate is diluted with water forming a use solution with aconcentrate to water ratio from about 1:1 to about 1:10.
 17. Anantimicrobial use solution comprising: (a) a cationic active ingredient,wherein the cationic active ingredient is an inorganic salt of anaromatic quaternary ammonium containing compound; (b) a foam boostingsurfactant; (c) from about 0.05 wt. % to about 18 wt. % of a foamboosting copolymer; (d) a foam stabilizing, linear or branched C₅₋₁₂diol with the structure

wherein R₁═H, CH₃, CH₂CH₃, CH₂CH₂CH₃, C(CH₃)₃, CH(CH₃)₂ or combinationsthereof and R₂ is a branched or linear C₁-C₉ alkyl chain; (e) anaminocarboxylate chelating agent capable of forming a calcium-chelatingagent complex with a stability constant (expressed logarithmically) of5.5 or greater; and (f) water, wherein said use solution issubstantially free of anionic surfactants and substantially free oftriclosan.
 18. The antimicrobial use solution of claim 17, wherein theuse solution comprises from about 100 ppm to about 50,000 ppm of atleast one cationic ingredient selected from the group consisting of:alkyl dimethyl benzyl ammonium chloride (ADBAC), alkyl dimethylethylbenzyl ammonium chloride, and benzethonium chloride.
 19. Theantimicrobial composition of claim 17, wherein the said foam boostingsurfactant comprises a quaternized alkylpolyglucoside, a quaternaryalkyl polyglucoside, and alkyl amine oxide, alkyl ether amine oxide andpolyethoxylated glycerol esters, or combinations thereof.
 20. Theantimicrobial composition of claim 17 wherein the composition comprisesfrom about 50 ppm to about 50,000 ppm of foam boosting surfactant. 21.The antimicrobial composition of claim 17 wherein said foam boostingpolymer is a dimethyldiallylammonium chloride-acrylamide copolymer. 22.The polymer of claim 17 wherein said dimethyldiallylammoniumchloride-acrylamide copolymer has a molecular weight from about 500,000to about 5,000,000 g/mol.
 23. The antimicrobial concentrate of claim 17wherein said a foam stabilizer is a linear or branched C₅₋₁₂ diol withthe structure

wherein R═H, CH₃, CH₂CH₃, CH₂CH₂CH₃, C(CH₃)₃, CH(CH₃)₂ or combinationsthereof and R₂ is a branched or linear C₁-C₉ alkyl chain.
 24. Theantimicrobial composition of claim 17 wherein the foam stabilizer ishexylene glycol.
 25. The antimicrobial composition of claim 19 whereinthe chelating agent is ethylenediamine tetraacetic acid (EDTA),diethylenetriaminepentaacetic acid (DTPA), methylglycine diacetic acid(MGDA), glutamic acid-N,N-diacetic acid (GLDA), asparticacid-N,N-diacetic acid (ASDA) and alkali metal and/or ammonium saltsthereof.
 26. The antimicrobial composition of claim 25 wherein thechelating agent is present from about 10 ppm to about 20,000 ppm.
 27. Amethod of reducing bacterial, microbial, fungicidal or viral populationon a dermal tissue of a mammal comprising the step of: contacting thedermal tissue of a mammal with the use solution of claim 17 for asufficient time to provide substantial bacterial, microbial, fungicidalor viral reduction.
 28. The method of claim 27 wherein the sufficientcontact time is approximately about 1 to about 60 seconds.
 29. Themethod of claim 27 wherein the dermal concentrate is rinsed off of thedermal tissue after contact or remains on the dermal tissue aftercontact.
 30. The antimicrobial dermal concentrate of claim 1, whereinthe inorganic salt of an aromatic quaternary ammonium containingcompound is alkyl dimethyl benzyl ammonium chloride (ADBAC).